MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow up medwatch will be submitted when additional information becomes available.

Event Description

The event occurred in the us.It was reported that the customer received 2 hls sets with punctured packaging.No more information provided.No indication of actual or potential for harm or death has been reported.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the customer received 2 hls sets with punctured packaging.The affected products (2 pieces) were technically investigated at the laboratory of the manufacturer.Hereby a hole (dimensions 30,5mm x 16,6mm sample 1; 11,6mm x 3,8mm sample 2) was detected within tyvek cover of each hls intellipack 1.The sealing of the tyvek cover was still intact.After opening of the intellipack 1 it was detected that the 2 velcostraps (used for fixating hls module) were a bit loose.At the bottom of the intellipack one velcostrap was not fixated with adhesive tape which allows the velcostrap to slip and this led to a less fixated hls module.The weld points of the welded inlay of the intellipack 1 were still intact.The most probable cause of the reported failure "punctured packaging" was determined to be an inadequate fixation of the hls module onto the insert of the intellipack.This led to vertical movement of the hls module during transport whereby the brackets of the venous measurement cell holder at the blood inlet connector pierced the sterile tyvek cover of the intellipack 1.Thus the reported failure "hole in sterile hls set cover" could be confirmed.The root cause analysis of the manufacturer is still ongoing.

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The most probable cause of the reported failure "punctured packaging" was determined to be an inadequate fixation of the hls module onto the insert of the intellipack due to a missing adhesive tape.This led to vertical movement of the hls module during transport whereby the brackets of the venous measurement cell holder at the blood inlet connector pierced the sterile tyvek cover of the intellipack 1.As a preventive action mcp production was informed about the investigation results and a retraining of the affected process was performed.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿ s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint id: (b)(4).

• Brand Name: HLS SET ADVANCED
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 12663755
• MDR Text Key: 277344125
• Report Number: 8010762-2021-00562
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2022
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701052794
• Device Lot Number: 3000179558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1